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ACTIVE NOT RECRUITING
NCT03807531
NA

A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee

Sponsor: ReFlow Medical, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions. This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland. At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site). The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.

Official title: A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2019-07-11

Completion Date

2028-06-01

Last Updated

2023-11-18

Healthy Volunteers

No

Interventions

DEVICE

Temporary Spur Stent System

Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines

Locations (6)

Klinikum Hochsauerland Klinik für Angiologie

Arnsberg, Germany

Universitats Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

RoMed Klinikum Rosenheim

Rosenheim, Germany

Auckland City Hospital

Auckland, New Zealand

Ospedale di Lugano Civico

Lugano, Switzerland